Women's Health Behaviors Stages of Change (Transtheoretical Model) in Preconception Period: A Randomized Control Study

February 6, 2020 updated by: Yasemin ERKAL AKSOY, Ege University

H0: Preconceptional preparatory training period between pregnancies with and without women is no difference in terms of changes in health behavior.

H1: Preconceptional preparatory training period between pregnancies with and without women there is a difference in terms of changes in health behavior.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In order to reach for the second follow-up of women both her and her partner/mother phone number were registered.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey, 42250
        • 17 Number Family Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Accept to participate in the research and have signed the informed consent form,
  • Being over 18 years old,
  • To be literate,
  • Lack of a psychological diagnosis,
  • To be married,
  • Having no pregnancy,
  • Pregnancy is thought.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Preconception guidance prepared by reference to the guidelines published in the literature, women were given pre-pregnancy training.
Other: Pregnancy preparation training
Pregnancy preparation education; folic acid use, physical activity, nutrition, addictions counseling issues are included.
No Intervention: Control
The women in the control group were not given training, and routine practice was performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Women's behavior change phase
Time Frame: eight weeks
The research was conducted by the researcher to evaluate the stages of behavior change related to the topics covered in preconceptional care. With the response to the questions, it is possible to determine which behavior change stage of the individuals. Women's behavioral changes were evaluated according to the five change stages on the transtheventional model. For the detailed evaluation of the individuals who are in the process of moving and maintaining, open-ended questions specific to each subject were asked.
eight weeks
Healthy Lifestyle Behavior Scale-II
Time Frame: eight weeks
Walker et al. (1987) developed a scale to evaluate health-promoting behaviors related to the individual's healthy lifestyle. Validity and reliability study was conducted by Bahar et al. (2008). The scale consists of 52 items and all items are positive. The rating is in the form of a four-point likert (1), sometimes (2), often (3), regularly (4). The lowest score is 52 and the highest score is 208. The total score of the scale determines the healthy lifestyle behavior score. The scale consists of six sub-dimensions: Health responsibility, Physical activity, Nutrition, Spiritual development, Interpersonal relations, Stress management.
eight weeks
General Self-Efficacy Scale
Time Frame: eight weeks
The scale was developed by Ralf Schwarzer and Mattihias Jerusalem (1995) in order to make a general assessment of perceived self-efficacy. The validity and reliability study of the scale was conducted by Aypay (2010). The scale applied to individuals aged 12 years or older consisted of 10 items. Self-sufficiency scale scores vary from 1 to 4 each. The lowest total score obtained from the scale is 10 and the highest score is 40. The high score from the self-efficacy scale indicates that the self-efficacy level is high.
eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

July 16, 2019

Study Registration Dates

First Submitted

March 7, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 28, 2019

Study Record Updates

Last Update Posted (Actual)

February 10, 2020

Last Update Submitted That Met QC Criteria

February 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0000-0002-7453-1205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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